United States Prevention, Pesticides April 1998
Environmental Protection And Toxic Substances " EP/^ 735-F-980-04
Agency ' . • (750BC) •
For Your Information
Consumer Products
Treated with Pesticides
Background
In recent years, consumers have been increasingly concerned about the presence
of bacteria in or on various items. In response to these fears, many consumer products
that are treated with antimicrobial pesticides have appeared in the marketplace. These
products bear implied or explicit public health pesticidal claims to protect the public
against harmful microorganisms ~ bacteria, fungi, and viruses. Some of these products
include cutting boards, kitchen sponges, cat litter, toothbrushes, and juvenile toys.
Under the Federal law that regulates pesticides, the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), companies cannot make public health pesticidal claims for
any product distributed or sold
unless the product has been
EPA regulates pesticides that kill microbes
such as bacteria, viruses, or algae on non-
living surfaces. Antibacterial soaps, lotions,
and other similar personal-care products
are regulated by the Food and Drug
Administration.
approved and registered (licensed)
by EPA, Or is covered by an ~
exemption from registration. If
covered by an exemption, such a
product may claim only that it
contains'a pesticidal preservative
to protect the product itself.
These pesticides are known as
materials preservatives.
Consumer and other products that incorporate materials preservative pesticides in order to
preserve the product itself, or for other purposes, are called "treated articles." EPA has
seen no evidence that these products prevent the spread of germs and bacteria in humans.
Pesticide treated products that are not registered by EPA cannot make any public health
claims, such as "fights germs," "provides antibacterial protection," or "controls fungus."
Nonetheless, these types of unauthorized public health pesticidal statements are
. being made. EPA is concerned about these statements because, in addition to being
unlawful, they also are potentially harmful to the public — if people believe that the
product has a self-sanitizing quality, they may not practice standard hygiene to prevent the
transmission of harmful germs.. Consequently, the public's health may be less protected.
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For that reason, EPA advises consumers not to rely, on antibacterial claims as a
substitute for following common-sense hygienic practices. EPA does not know whether
these treated products work as claimed.
As a result, EPA is seeking public comments on a recently issued draft guidance
document that would describe the types of claims that can be made about pesticide treated
products. Once final, the guidance will be intended to set forth EPA's policy with respect
to the scope of the treated articles exemption [40 CFR 152.25 (a)]; provide examples of
acceptable and unacceptable claims; and give examples of wording that would be
acceptable for use on labels and advertisements for products that qualify for the treated
articles exemption. This action will be intended to help consumers make more informed
decisions about protecting their health, and to serve as the basis for preventing illegal,
unsubstantiated, and potentially harmful public health claims from being made for
unregistered consumer products treated with pesticides.
Current EPA Approach to Pesticide Treated Articles
All products that ,
make pesticidal claims
must be registered by EPA
before they may be legally
marketed in the United
States, unless they are
exempt from registration.
Under FIFRA, EPA
created a limited
exemption to allow
pesticide treated articles to
be sold without an EPA
registration so long as
product claims are limited
to protection of the treated
product itself. The treated
articles exemption is set
forth in 40 Code of
Federal Regulations
152,25 (a).
"Treated Articles" are consumer and other
products that incorporate antimicrobial
pesticides in order to preserve the product
itself or for other purposes. Examples that
fall within the treated articles exemption
are paint treated with a registered pesticide
to protect the paint coating from mold, and
wood products, such as telephone poles,
treated to protect the wood against insect
or fungus infestation. In both cases the
pesticide is registered for the intended use,
and the sole purpose of treatment is to
protect the article itself. Pesticides used in
this manner are generally classified as
preservatives and are widely used in the
manufacture of textiles, plastics, paper,
adhesives and coatings.
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An exempt product can not make implied or explicit public health claims (e.g.,
"kills germs," "stops E. coli ...")• Treated articles making public health claims must be
registered with_EPA. To obtain a registration, EPA requires specific efficacy data to
support the product's public health labeling claims for the patterns of use, and other data
to support the product's safety. Such products must meet other applicable registration .
requirements. --'•".
•—s '•--.'.. ' '
Proposed Guidance for Treated Articles
The proposed guidance, once final, is intended to clarify the conditions under
which the treated articles exemption will apply:
> Claims for treated articles or substances are limited to the following statement, "This
product contains a preservative (e.g., fungicide or insecticide) built-in (or applied .as a
coating) only to protect the product." ,
The treated articles exemption
is available only for article
protection and not for esthetic.
or public health uses.
Treated kitchen accessories or
other food contact articles
such as a cutting board, high
chair or conveyor belt that
may come in contact with food
must carry the following
qualifying statement, "This
product does not protect users
or others against food-borne
bacteria. Always clean and
wash this product thoroughly
before and after each use."
Until the proposed guidance policy is final,
the following language is an example of an
acceptable non-public health claim for a
product such as a sponge or cutting board:
"Antibacterial properties are built-in to
inhibit the growth of bacteria that may
affect .this product. The antibacterial
properties do not protect users or
others against bacteria, viruses, germs,
or other disease organisms. Always
clean and wash this product
thoroughly before and after each use."
Treated products that involve potential human contact with bodily fluids or excrement,
e.g., blood, vomit, saliva, urine or feces, must carry the following qualifying statement,
"This product does not protect users against bacteria, viruses or other disease '
organisms. Always clean and wash this product thoroughly before and after each use."
Bed pans and potty seats are examples of these products.
The preservative claim and qualifying statement on the product packaging (type, size,
color) must be given no greater prominence than other described product features.
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Compliance with the elements set forth in the PR Notice will be expected no later
than 60 days following issuance of the final policy notice in order to give affected
companies time to bring products into compliance. However, the Agency strongly
encourages companies to conform their marketing of products to the proposed guidance
notice as soon as they can.
1 ' '-"V, „
Current Enforcement of the Treated Articles Exemption
The treated articles exemption in 40 CFR Part 152.25 (a) was established in 1988.
Since that time, enforcement actions have been taken against companies where the Agency
deemed it necessary. The products involved in these actions were dealt with so as to
resolve individual issues arising in each matter. As a result of the large variety of treated
products and substances with diverse claims that have appeared in the marketplace, the
Agency intends to replace this approach with comprehensive guidance to be set forth in a
PR Notice. Until such guidance is in effect, the Agency will continue to use the current
approach. Based on the enforcement cases to date, that approach includes the following
elements:
>• registered pesticides must be used to treat the treated article;
1 *i ' ,''''.
>• no implied or explicit public health claims of any kind are made;"
»• the claims concerning the presence of a pesticide in the treated article are limited to
protection of the treated article'only; and
>• when such claims involve antibacterial properties, a] the words "antibacterial,"
"antimicrobial," or "germicidal," or related terms, are not a part of the name of the
product, and b] the permissible claims are qualified by statements indicating that the
presence of the antibacterial properties does not protect users and others against
disease and that users should follow prudent hygienic measures, i.e., cleaning and
washing the article.
Enforcement Actions
To address the growing trend of marketing unregistered pesticide treated products
with illegal, unsubstantiated public health claims, EPA headquarters and Regional Offices
have acted quickly and decisively to prohibit sales of these products by taking more than a
dozen enforcement actions. EPA will continue to take action against companies that make
illegal claims.
What Consumers Can Do
While EPA has no basis for concern that the presence of these antimicrobial
pesticides in consumer products could directly harm users, there are some common sense
steps consumers can take to reduce the spread of germs, such as:
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>• wash hands frequently and thoroughly;
>• wash surfaces that contact food with a detergent arid water (e.g., utensils, cutting
boards, counter tops); and
»• wash children's hands and toys regularly.
For More information
Electronic copies of the Federal Register announcement and guidance notice are
available from the EPA Home Page at the Federal Register - Environmental Documents
entry under Laws and Regulations (http://www.epa.gov/fedrgstr/). To receive a fax copy
of either document, call (202) 401-0527 and ask for item 6110. To obtain more ,
information about the proposed guidance, contact Walter Francis, Environmental
Protection Agency, (MC 7510W), 401 M St., SW., Washington, DC 20460, (703) 308-
6419 (phone) or (703) 308-4687 (fax); email: francis.walter@epamail.epa.gov.
EPA is accepting .public comments on the proposed guidance notice until
May 18, 1998. Submit written or electronic comments identified by the docket control
number OPP 00530 by mail to: , . '
Public Information and Records Integrity Branch, Information, Resources and Services
Division (7502Q, Office of Pesticide Programs, Environmental Protection Agency
401 M Street, SW, Washington, DC 20460. In person, bring comments directly to the OPP
Docket Office, 1921 Jefferson Davis Highway, Room 119 of Crystal Mall #2, Arlington, VA.
Comments may also be submitted electronically to: oppdocket@epamail.epa.gov.
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